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CTRI Number  CTRI/2023/04/051262 [Registered on: 03/04/2023] Trial Registered Prospectively
Last Modified On: 09/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics]  
Study Design  Single Arm Study 
Public Title of Study   Skin pores benefits study 
Scientific Title of Study   Efficacy Evaluation Of Cosmetic Formulations In Conferring Skin Pore Constricting Benefits in Healthy Human Participants. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SKIN/ITPC/2023-02 Version 1.0 Dated 14 Mar 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukesh Ramnane 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Second floor, Evaluation room, Interface, no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  mukesh.ramnane@msclinical.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mukesh Ramnane 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Second floor, Evaluation room, Interface, no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor


KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  mukesh.ramnane@msclinical.com  
 
Details of Contact Person
Public Query  
Name  Dr Mukesh Ramnane 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Second floor, Evaluation room, Interface, no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor


KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  mukesh.ramnane@msclinical.com  
 
Source of Monetary or Material Support  
ITC Life Sciences & Technology Centre, Peenya Industrial Area, I Phase, Peenya,Bangalore- 560058, Karnataka, India.  
 
Primary Sponsor  
Name  ITC Life Sciences Technology Centre  
Address  Peenya Industrial Area, I Phase, Peenya  
Type of Sponsor  Other [FMCG(Fast moving Consumer Goods)] 
 
Details of Secondary Sponsor  
Name  Address 
None  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mukesh Ramnane  MS Clinical Research Pvt. Ltd.  Second floor, Evaluation room, Interface, no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor
Bangalore
KARNATAKA 		 08041125934
08040917253
mukesh.ramnane@msclinical.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy male and female participants  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  None  NA 
Intervention  Skin Pore Tightening Serum (PMS 127-089)  Approximately 5-7 drops (0.5 to 0.6g) of the product to be applied evenly on entire face, each time, once in the morning after bath and once in the evening after washing face with the provided face wash, for a period of 4 weeks. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Participants in the age group of 19 to 50 years
2· Participants with enlarged skin pores, varied skin types including Sensitive skin
3· Participants willing to abide by the study protocol and refrain from using any product other than the provided Investigational product during the study course.
4· Participants with varied skin type i.e., normal, dry, oily, combination and sensitive skin in nearly equal ratio.
5· Participants willing to visit the site for periodic assessments on the scheduled dates.
6· Participants who exhibits good tolerance to the investigational product with no signs of sensitivity.
7· Participants who agree to refrain from any other test product during the study
8· Participants willing to give voluntary written informed consent and photography release.
9· Participants willing to abide by and comply with the study protocol.
10· Participants able to read and sign an appropriate informed consent form indicating their willingness to participate.
11· Participants willing and capable to follow the study rules and a fixed schedule. 
 
ExclusionCriteria 
Details  1. Pregnant or lactating women
2· Participants undergoing treatment for Seborrhoea, Acne, Dermatitis, skin lightening/ any other cosmetic/ dermatologic skin condition on face
3· Participants with pre-existing systemic disease requiring long-term medication (self-declaration)
4· Participants with genetic and endocrinal disorders [ self-disclosure]
5· Participants with drug induced acne [ self-disclosure]
6· Participants with any other signs of significant local irritation or skin disease.
7· Participants on oral hormonal treatment or oral medications (e.g., steroids, anti-oxidant) for eight weeks prior to the study which will compromise the study.
8· Participants who may change personal nutrition habits and other habits as per investigator’s discretion.
9· Participants who have participated in a similar investigation or any other clinical product evaluation test in the past four weeks
10· Participants under the influence of alcohol and/or drugs as well as addiction.
11· Participants with severe psychological illness or intellectual inability to understand the study.
12· Participants who have wounds, sunburn, scars, tattoos or piercings at the skin test sites.
13· Participants with uncontrolled disease (severe heart/circulatory, liver, kidney or lung disease, severe diabetes mellitus) or chronic infections (hepatitis, HIV)
14· Participants who have proven allergies against cosmetic ingredients or prior intolerance responses after applying cosmetic products.[ self-disclosure]
15· Participants who are taking antihistamines and/or medication to suppress the immune system (e.g., corticoids, cytostatics) and/or retinoids
16· Participants who might participate in any other clinical study during participation in the current study
17· Participants currently taking any medication, which the investigator believes may influence the interpretation of the data.
18· Participants having chronic or acute skin disease at the skin test sites within the last 14 days prior to the beginning of the study and/or during the study or had major surgery in the last year.
19· Participants undergoing any treatment of any active skin condition
20· Participants allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else.
21· Participants who are pregnant or nursing. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in the visibility of skin pores as per Dermatologist’s and / or Participants’ assessment
2· Reduction in the area, density, volume of facial skin pores as per objective assessment
3· Reduction in sebum as per instrumental measurements and Participants’ assessment
4· Reduction in comedones (Blackheads, Whiteheads) 		 4 weeks of product use 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in below mentioned skin parameters as per Dermatologist’s assessment, Participants assessment and Instrumental measurements
· Texture
· Epidermal turnover rate / Desquamation
· Hydration/ Moisturization (Instant, Longevity and Deeper)
· Firmness / Resilience
· Radiance
· Even tone
· Clarity
· Softness
· Smoothness 		 4 weeks of product use 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/04/2023 
Date of Study Completion (India) 12/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Part 1:

The study will be conducted for a period of approximately 4 weeks. On visit 1, the subjects will be selected based on the inclusion and exclusion criteria and will be enrolled after obtaining informed consent. On visit 2, baseline assessments (T0) will be evaluated through visual assessments by Dermatologists, Instrumental evaluations and subjects’ self-assessment.

The subject will be provided with the test product to apply on full face after face wash under the supervision of the study coordinator. Then 1h assessments (1hr after product application) will be performed.

Post completion of the assessment, the subject will be dispensed with the test product and subject diary to carry home and instructed to use for 4- weeks after washing of the face with provided cleanser.

The subjects will be instructed to visit the study centre at day 1, 3, Week 1, 2, 3 & 4 for the follow up assessments.

Part 2:

On visit 2, Two test sites will be identified on the subject’s forearm. The test site identification will be followed by baseline corneometer measurement. Then the test products will be applied on each of the identified sites on the forearm as per randomization. Post 15 min (+15min) of test product application & 72 hrs corneometer measurements will be performed. 20 layers of tape stripping will be performed post product application on the identified test sites and Corneometer measurements will be performed on 0 (before tape stripping), at the end of 5th strip, 10th strip, 15th strip  and 20th tape strip.
 
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